Hydrox Laboratories
Form 483 issued June 9, 2016 · Elgin, Illinois
- Inspection
- May 10 – Jun 9, 2016
- Investigators
- Brian D. Nicholson· Goran Periz· John Misock
- Observations
- 7
- Pages
- 7
- FEI number
- 1419821
In short: On June 9, 2016, FDA issued a Form 483 with 7 observations to Hydrox Laboratories in Elgin, Illinois (FEI 1419821) after an inspection that ran May 10 – Jun 9, 2016. The investigators were Brian D. Nicholson, Goran Periz and John Misock. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 3 systems, led by quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your cosmetics were prepared, packed or held under insanitary conditions whereby they…
- 02
Products that fail to meet established specifications…
- 03
The firm's procedures do not require routine documented investigation of microbiology laboratory failures such as when…
- 04
Management of the firm's long term stability program is deficient in that on 05/10/16, I (BDN)…
This inspection in context
Brian D. Nicholson
20 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmHydrox Laboratories history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hydrox Laboratories?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Hydrox Laboratories?
Brian D. Nicholson, Goran Periz and John Misock are named on this Form 483, for the inspection of May 10 – Jun 9, 2016. Each investigator has a profile showing what they cite most.
When was Hydrox Laboratories inspected by FDA?
The inspection ran May 10 – Jun 9, 2016, and the Form 483 is dated June 9, 2016.
How do I get the full Form 483 for Hydrox Laboratories?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.